What's Making News At Aastrom?

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Shares of regenerative medicine company Aastrom Biosciences Inc. (ASTM) have been on a roll lately, up nearly 179% over the past one month, as it prepares to advance its vascular regeneration clinical program to phase III.

The company has two clinical programs that are underway, namely, cardiac regeneration and vascular regeneration trials. The vascular regeneration program is evaluating autologous bone marrow cells in patients with peripheral artery disease to treat critical limb ischemia, or CLI. The cardiac regeneration program is evaluating expanded autologous cellular therapies in the treatment of DCM (dilated cardiomyopathy).

In order to strengthen its long-term manufacturing capabilities, Aastrom formed a new strategic partnership with medical device manufacturer ATEK Medical last month. Under the collaboration, ATEK Medical will supply key components and technology for use in Aastrom's proprietary cell manufacturing process.

Aastrom is scheduled to present data from an interim analysis of its phase IIb study dubbed RESTORE-CLI at a VEITHsymposium non-CME satellite session on November 18. The non-CME events are educational programs for medical professionals and are aimed at promoting a product or therapy.

The company had presented encouraging results from an interim analysis of the phase IIb RESTORE-CLI clinical trial at the Society for Vascular Surgery Annual Meeting in June. Enrollment of the RESTORE-CLI trial is complete , and patient follow-up is ongoing.

It is estimated that about 400,000 people in the U.S. are affected with critical limb ischemia, leading to over 160,000 major limb amputations per year. About 25% of the CLI patients die within six to 12 months of diagnosis and only less than 25% of patients survive four years.

The gold standard for the treatment of CLI is bypass surgery but even this fails when the tibial vessels are severely diseased. Gene therapies, which have been tested for CLI, have also disappointed. In September of this year, NV1FGF, a gene therapy developed by Vical Inc. (VICL) and licensed to Sanofi-Aventis (SNY), failed to demonstrate superiority over placebo in preventing leg amputations and death in a phase III trial.

With gene therapy failing to live up to its hype in CLI, cell-based therapies like the ones being developed by Aastrom are expected to be the next stop.

Aastrom's proprietary Tissue Repair Cell, or TRC, technology uses a patient's own cells (harvested from bone marrow) for the treatment of severe, chronic cardiovascular diseases. Since a patient's own cells are used, the risk of cell rejection is minimized and disease transmission risk from donor tissue is also eliminated.

Late last month, the company submitted a SPA (Special Protocol Assessment) to the FDA for its phase III CLI program. The FDA is expected to respond in 45 days. If the FDA concurs with the protocols outlined in the SPA, Aastrom expects to initiate the phase III program early next year.

The cardiac regeneration program, which is evaluating expanded autologous cellular therapies in the treatment of dilated cardiomyopathy, has two trials in phase II - IMPACT-DCM and Catheter-DCM.

Aastrom is a development stage company and has yet to report profits. Through September 30, 2010, the company had accumulated a net loss of approximately $218.42 million and had a total of about $14.5 million in cash and cash equivalents. The cash on hand to finance the company's operations is expected to last until at least June 30, 2011. However, if necessary the company will need to raise additional funds in order to complete its product development programs, complete clinical trials needed to market its products (including for a phase III clinical trial for CLI), and commercialize these products.

ASTM has 28.25 million shares outstanding and a float of 26.48 million. The short interest ratio is 0.5. (Data sourced from Yahoo Finance). The stock, which has thus far hit a 52-week low of $1.32 and a 52-week high of $4.22, closed Tuesday's trade at $4.10.

Aastrom, which is racing to find an effective cell therapy for critical limb ischemia, seems to be hitting its stride. Stay tuned.

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